MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid®

Rhea-AI Summary

MediWound (Nasdaq: MDWD) completed commissioning of its expanded GMP manufacturing facility in Yavne, Israel on November 3, 2025, marking a step toward full operational readiness by year-end 2025. The expansion is expected to increase NexoBrid production capacity by approximately sixfold, aiming to support supply across more than 40 approved markets. The company says the facility will enable a scalable, reliable global supply once regulatory reviews are complete. Market availability remains subject to the completion of those regulatory reviews.

Positive

• Commissioning completed on November 3, 2025
• Production capacity expected to increase by ~6x
• Targeting full operational readiness by year-end 2025
• Supply aimed for >40 approved markets

Negative

• Market availability subject to regulatory review, creating timing uncertainty

MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid^®

Newly commissioned facility marks a significant development toward a sixfold production capacity increase ahead of full operational readiness by year-end 2025

YAVNE, Israel, November 3, 2025 – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the successful completion of the commissioning process for its expanded GMP manufacturing facility in Yavne, Israel. This milestone represents an important positive development toward full operational readiness and expanding the Company’s capacity to meet rising global demand for NexoBrid^®.

“We are pleased to complete the commissioning of our expanded facility,” said Shmulik Hess, Ph.D., Chief Operating and Commercial Officer of MediWound. “Following regulatory review, we will be well positioned to ensure a reliable, scalable global supply of NexoBrid across more than 40 approved markets. This achievement reflects our team’s dedication to operational excellence and our commitment to providing physicians and patients with timely access to NexoBrid.”

The expanded facility, which is expected to achieve full operational readiness by year-end 2025, will increase production capacity for NexoBrid by approximately sixfold, enabling scalable, reliable supply to meet the product’s growing global demand. Market availability remains subject to the completion of regulatory reviews.

About NexoBrid^®

NexoBrid^® is a topically administered, biological orphan drug for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns. It selectively removes non-viable tissue while preserving viable tissue and is approved for use in adults and pediatric patients in over 40 countries, including the United States, European Union, and Japan.

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved biologic, NexoBrid^®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx^®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.

For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter).

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid^®; the timing and success of operational readiness by year-end 2025, the likelihood to successfully complete the regulatory reviews and our ability to meet global demand. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with market acceptance of NexoBrid; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

MediWound Contacts:        

Hani Luxenburg        
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com

Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

Media Contact: 
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com+1-929-588-2008

FAQ

What did MediWound (MDWD) announce on November 3, 2025 about its Yavne facility?

MediWound announced completion of commissioning for an expanded GMP facility in Yavne, advancing toward full operational readiness by year-end 2025.

How much will MediWound increase NexoBrid (MDWD) production capacity after expansion?

The expanded facility is expected to increase NexoBrid production capacity by approximately sixfold.

When will MediWound's (MDWD) expanded Yavne facility be fully operational?

The company expects the facility to achieve full operational readiness by year-end 2025.

Will NexoBrid (MDWD) availability expand to new markets after the facility upgrade?

The company intends to supply NexoBrid across more than 40 approved markets, subject to regulatory review.

Does the MediWound (MDWD) announcement include financial guidance or cost details?

No; the announcement reports commissioning and capacity plans but does not provide financial guidance or cost figures.

What is the main investor risk from MediWound's (MDWD) facility expansion?

Primary risk is that market availability and supply timing remain contingent on completion of regulatory reviews.